All Eyes on Watchman FDA Panel Meeting in December

The FDA has set the date (December 11th) for its Circulatory System Devices Panel of the Medical Devices Advisory Committee. At the event, said committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure Technology.

Background

We’ve covered the developing story of the Left Atrial Appendage and the collection of devices being pitched at making sure it doesn’t eject any clots into the blood stream during atrial fibrillation bouts. Boston scientific’s WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. The device is descibed as being intended to prevent thrombus embolization from the left atrial appendage, thereby preventing the occurrence of ischemic stroke and systemic embolism, and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy.

The FDA will be providing meeting notes in advance of the event, so we can all have a look at their worries and deepest thoughts with regard to this technology. As can the panel. It should all be very interesting, not least because these permanently indwelling devices aren’t without a degree of conjecture. Not all cardiologists are sanguine about the concept, for a variety of reasons: The procedure is tricky and highly dependent on operator skill, the LAA doesn’t lend itself to closure so can continue to leak, other (good) alternative stroke prevention measures exist, and finally, the device, once endothelialised, is pretty much staying put.

In its favour, results from Boston Scientific’s PREVAIL study appear to indicate that the device met its primary endpoints, which will presumably carry weight with the panel. Sadly it didn’t meet its secondary endpoints. It might come down to the panel’s interpretation of the notion that one procedure, albeit invasive and difficult to reverse, may provide patients with a lifelong solution that trumps lifelong anticoagulant therapy. They will presumably either be advocates or not.